Kornimate/medical-research-clean huggingface dataset:
oral use of dexketoprofen/tramadol for acute postoperative pain in total hip replacement with a direct anterior approach.

Conditions: Postoperative Pain; Pain, Acute

Summary: pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . when unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. dexketoprofen is a new nsaid treating acute postoperative pain and when it combined with tramadol may have a better effect. the purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (amis).


Eligibility criteria:
inclusion criteria: * unilateral total hip arthroplasty with a direct anterior minimal invasive technique * asa score i or ii * signed written informed consent form * 3 days hospitalization * 45-80 years old * primary total hip arthroplasty exclusion criteria: * allergy to any given drugs * contraindications for spinal anesthesia * active bleeding * renal failure ( gfr\< 90ml/h) * hepatic failure ( abnormal sgot,sgpt,γgt) * heart failure * history of gastrointestinal bleeding
evaluation of the risk of nephrogenic systemic fibrosis (nsf) in patients with chronic kidney disease without exposure to gadolinium based contrast agents (gbca)

Conditions: Renal Insufficiency

Summary: the objective of this long term study is to prospectively evaluate the incidence of nsf in patients with severe ckd or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an egfr below 30)who have not had exposure to a gbca within 10 years prior to enrollment.


Eligibility criteria:
inclusion criteria: * has ckd with an egfr below 30 ml/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (scr) value obtained from the local laboratory within 24 hours prior to signing the informed consent; * provides written informed consent and is willing to comply with protocol requirements exclusion criteria: * has received a gbca within the past 10 years prior to inclusion in this study including the administration of a gbca for something other than an mri (e.g., ct or dsa); * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; * has ever been suspected of, or diagnosed with, nsf; * is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of nsf be suspected.
interest in electronic applications for patients with glaucoma

Conditions: Glaucoma

Summary: to evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers.

this study is designed to determine the amount of interest in an educational application (app) on social media for glaucoma patients and their caregivers. the purpose of this app is to enhance understanding of glaucoma by using short video tutorials. the app will include glaucoma eye drop medication reminders, a short video tutorial which aims to improve understanding of how visual field testing should be performed, how to administer eye drops and a feature that will enable participants to store and organize testing results using a mobile device.

Eligibility criteria:
inclusion criteria: * anyone affected by glaucoma * family and friends of someone with glaucoma exclusion criteria: * unable to complete survey

Keywords: glaucoma smartphone tablet application eye drops
study on the effectiveness of journaling as an add-on to cognitive behavioral therapy

Conditions: Affective Disorders; Rumination; Childhood Trauma; Eating Disorder; Substance Use Disorder; Personality Disorder; Mental Disorder

Summary: the aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (cbt). homework assignments are a fundamental component of behavioral therapies. in line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. one way to enhance individual goal setting and reflection in patients is through the use of "therapy journals." the goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (cbt). to do this, n = 80 psychotherapy patients will be randomly assigned to two treatment groups: cbt vs. cbt + journaling.

as part of this study, the investigators are examining the effectiveness of certain therapeutic techniques that could improve the effectiveness of psychotherapy. a total of 80 patients will be studied, and they will be assigned to one of two treatment groups: one group will receive standard treatment, while the second group will receive additional tasks/techniques. the study will span a period of 24 sessions (short-term psychotherapy kzt1\&2), during which the severity of their symptoms will be assessed at the beginning of each session (duration approx. 2 minutes). additionally, participants will be asked to answer some questions about basic documentation (diagnoses, symptoms) at the beginning and end of the study (duration approx. 20 minutes). the investigators assure that the personal data they collect will be protected in accordance with the european data protection regulation. collected data will only be analyzed in anonymized form, meaning without mentioning any names, and may be published in scientific journals. all data will be stored in encrypted form using personal codes. all data will be digitally archived for a period of 10 years on a well-secured drive at the university hospital tübingen; only the study leaders (dr. rosenbaum and dr. ehlis) are authorized to re-identify the data. the investigators would like to inform that the collected data will not be used for diagnostic purposes regarding possible pathological changes. there are no health risks associated with this study, and while it is unlikely to benefit personally from it, the participation will contribute to scientific knowledge.

Eligibility criteria:
inclusion criteria: * patients in ambulant cognitive behavioral therapy exclusion criteria: * none
exercise, acupuncture and fibromyalgia

Conditions: Fibromyalgia; Juvenile

Summary: set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.

fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. it is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. the diagnosis is essentially clinical, with no abnormal laboratory and radiological features physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. in general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. to date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia. the significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.

Eligibility criteria:
inclusion criteria: * juvenile fibromyalgia diagnosis * age between ten to seventeen years and eleven months exclusion criteria: * previous treatment with acupuncture; * treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month; * inflammatory diseases, hypothyroidism and hyperthyroidism

Keywords: juvenile fibromyalgia acupuncture exercise training
assessment of somatic symptom burden

Conditions: Somatization Disorder

Summary: the patient health questionnaire-15 (phq-15) is a frequently used questionnaire to assess somatic symptom burden. the somatic symptom scale china (sss-cn) was recently developed as a comprehensive self-report instrument in assessing somatic symptom burden, but its assessment value has not yet been widely tested in a nationwide. the study aims to investigate the reliability of the sss-cn, to validate discriminate validity and factorial validity, and to investigate its utility in patients with suspected coronary artery disease (cad) based on multi-centers inpatients.

somatic symptoms are prevalent in kinds of medical conditions and mental disorders. since they are associated with decreased quality of life, increased psychological distress, and increased use of health care services, the assessment of somatic symptom burden is essential in evidence based patient care and research. the patient health questionnaire-15 (phq-15) is a frequently used questionnaire to assess somatic symptom burden, but in which there are not any mental symptoms listed. recently, we developed the somatic symptom scale china (sss-cn) which includes common mental symptoms and more comprehensive somatic symptoms to assess somatic symptom burden, but its assessment value has not yet been widely tested. the aim of our study is to investigate the reliability and validity of the sss-cn compared with the phq-15. we also try to use the sss-cn to investigate the prevalence of somatic symptoms in patients with suspected coronary artery disease (cad) based on multi-centers inpatients.

Eligibility criteria:
inclusion criteria: 1. people who take the physical examination in renji hospital. 2. patients with suspected cad. exclusion criteria: 1. people who have been previously confirmed serious medical conditions. 2. people who have been previously confirmed serious mental disorders.

Keywords: somatic symptom sss-cn phq-15 suspected cad coronary angiography
evaluation of immediate and medium-term health- and work-related effects following inpatient psychocardiological rehabilitation

Conditions: Cardiovascular Diseases; Psychiatric Disorder

Summary: since may 2019, psychocardiological rehabilitation has been carried out at the rehabilitation center felbring (rfe) in the form of a pilot project. the background is the mutual relationship of psychological and physical morbidity, which is of particular importance in cardiological rehabilitation. the present outcome evaluation study is designed as a quantitative longitudinal study with 4 repeated measures, in which at least 75 rehabilitation patients will be included. three assessments are conducted at admission and discharge to/from inpatient rehabilitation, and an additional survey will be conducted by mail 6 months after the end of rehabilitation. effects that become apparent as a result of rehabilitation will be recorded from a patient-centered perspective by means of "patient-reported outcomes". in this way, primarily psychological and work-related changes, but also changes in the physical quality of life are to be mapped, which can be determined immediately after completion of rehabilitation and continue in the medium term up to 6 months later.


Eligibility criteria:
inclusion criteria: cardiovascular disease and increased psychological distress due to one of the following mental health diagnoses (according to icd-10): * depressive episode * recurrent depressive disorder * phobic disorders * anxiety disorders (incl. panic disorder) * acute stress reaction * post-traumatic stress disorder * adjustment disorders * other reactions to severe stress * psychological or behavioral factors that play a significant role in the etiology of physical illnesses exclusion criteria: * acute danger to self or others * acute mental disorders, the extent and/or instability of which does not allow participation in rehabilitation * high degree of neurocognitive deficits * highly degraded communication skills

Keywords: psychocardiology rehabilitation observational study return to work
determination of remifentanil's ed50 for rapid sequence intubation avoiding bradycardia and hypotension in adults

Conditions: Bradycardia; Hypotension

Summary: this study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life. remifentanil a potent opioid associated to bradycardia and hypotension at high doses.

Eligibility criteria:
inclusion criteria: * indication of anesthesia induction exclusion criteria: * protocol violation * monitoring problems
prospective follow-up of a cohort of pre-diabetics in the north of france (diabenord)

Conditions: Prediabetes

Summary: the purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.

type 2 diabetes (t2d) is a real public health issue, with an exponential incidence. before its diagnosis, several physiopathological changes are already taking place, such as insulin resistance of target tissues and the progressive inability of pancreatic beta cells to produce insulin. the objective of this study is a better understanding of the prediabetic stage and mechanisms involved in the possible development of t2d, by way of a five-year follow-up cohort study in 207 prediabetic subjects.

Eligibility criteria:
inclusion criteria: * previous history (within 2 months prior to enrollment visit) of fasting blood glucose ≥ 1,10 g/l and \< 1,26 g/l or fasting blood glucose ≥ 1 g/l and \< 1,10 g/l with hba1c ≥ 6,5%. exclusion criteria: * fasting glycemia ≥ 1.26 g/l * history of treatment with oral antidiabetics * history of treatment with insulin, except gestational diabetes * subject with any history or presence of significant hematologic (coagulation, thrombopenia, ...), hepatic, renal, or psychiatric disorders * subject unable to follow the study during the 5 years of follow-up * subject in exclusion period of a previous study or simultaneously participating to any other clinical trial on metabolism

Keywords: pre-diabetes type 2 diabetes biomarkers cohort diabetes risk score diabetes mellitus, type 2 glucose intolerance prediabetic state glucose metabolism disorders metabolic diseases endocrine system diseases hyperglycemia
epidemiology of severe peroperative bleeding during scheduled surgery

Conditions: Surgery; Blood Loss

Summary: peroperative bleeding has been studied in specific populations exposed to bleeding (i.e. cardiac surgery, orthopedic surgery). epidemiology of peroperative bleeding and transfusion remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown. the investigators conducted a prospective study in order to examine the incidence, and risk factors associated with peroperative bleeding and transfusion.

this was a prospective observational including all consecutive patients scheduled for surgery during a 3 month period. exclusion criteria were : emergency, cardiac surgery, and pediatric surgery. patients received an oral information and informed consent was search for all of them. throughout the study period (3 months) data were prospectively recorded by members of a specific research team not involved in the care of patients. preoperative, peroperative and immediate postoperative data (post anesthesia care unit) were collected. unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration \< 8 g/dl.

Eligibility criteria:
inclusion criteria: * patient scheduled for non cardiac and non emergency surgery exclusion criteria: * cardiac surgery * emergency surgery
non invasive ventilation (niv) related practices, monitoring of the niv treatment effect and of the patient's comfort

Conditions: Respiratory Failure Requiring Non Invasive Ventilation

Summary: the practices and processes related to the administration of noninvasive ventilation (niv) in the adult intensive care unit (icu) of the university hospital of lausanne will be recorded by an investigator at the bedside. the effect of the niv treatment on various respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be recorded using a pneumotachograph. finally patient's comfort during niv treatment will be evaluated.


Eligibility criteria:
inclusion criteria: * respiratory failure * therapeutic treatment by niv required exclusion criteria: * age \< 18 years old * prophylactic niv treatment * continuous positive airway pressure (cpap)treatment * denied consent

Keywords: non invasive ventilation respiratory failure respiratory comfort
a study evaluating the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in participants with estrogen receptor-positive, her2-negative locally advanced or metastatic breast cancer (persevera breast cancer)

Conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Summary: this phase iii, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (er)-positive, human epidermal growth factor receptor-2 (her2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * for women who are premenopausal or perimenopausal and for men: treatment with approved lhrh agonist therapy for the duration of study treatment * locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * documented er-positive tumor and her2-negative tumor, assessed locally * patients who have bilateral breast cancers which are both er-positive and her2-negative can be included in the study because the metastases are suitably targeted by the study treatments. if patients have bilateral tumors which are of different biomarker status, then proof of the er and her2 status of the metastases is required for study entry * no history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease * disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months * measurable disease as defined per recist v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by ct or mri which can be followed * eastern cooperative oncology group performance status 0-1 * adequate organ function exclusion criteria: * disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any cdk4/6 inhibitor * prior treatment with a selective estrogen receptor degrader (serd) * treatment with any investigational therapy within 28 days prior to study treatment * treatment with strong cyp3a inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization * advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term * known active uncontrolled or symptomatic cns metastases, carcinomatous meningitis, or leptomeningeal disease * active cardiac disease or history of cardiac dysfunction, as defined in the protocol * pregnant or breastfeeding
local ablative radiotherapy for oligoprogressive castration resistant prostate cancer

Conditions: Oligometastatic Disease; Prostatic Cancer, Castration-Resistant

Summary: the purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. the effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. treatment can be stereotactically hypofractionated or conventionally fractionated.

this is a monocentric, randomized, prospective phase ii intervention trial. efficacy is measured as the rate in patients with psa progression one year after randomization (defined as psa nadir after randomization +2 ng/ml). there is a 2:1 randomization between intervention and observation group. patients with psa progression in the observation group are offered a new diagnosis. this should preferably correspond to the initial diagnosis. therapy is performed for all patients in the intervention arm using high dose radiation therapy, either as conventional fractional irradiation with 2 gy/fraction up to a total dose of 50 gy or as hypofractional irradiation with a single dose of 10 gy up to a total dose of 30 gy. the decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.

Eligibility criteria:
indication: oligometastases (1-5) in castration-resistant prostate carcinoma inclusion criteria: * patient with good general condition (who 0-1) * histologically confirmed prostate carcinoma * after definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy). * psa progression under ongoing androgen deprivation (defined as three consecutive increasing psa values at intervals of \> 4 weeks and testosterone in the castration area \<50ng/dl or \<1.73nmol/) * minimum duration of androgen deprivation 6 months before inclusion in study * present complete staging (max. 6 weeks old), preferably by means of pet hybrid imaging with prostate-specific pet tracer * imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required) * no parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy * individual case discussion in an interdisciplinary tumor board * patient's ability to consent and written consent exclusion criteria: * severe concomitant disease that limits further life expectancy to \< 5 years according to the physician's assessment. * psa \> 20ng/ml, testosterone \>50 dl or \>1,73nmol/l * visceral metastasis (e.g. lung, liver, brain) * lack of compliance * previous taxane-containing chemotherapy

Keywords: oligometastatic disease prostate cancer radiation therapy prostatic cancer, castration-resistant